Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Symptoms: Change in defecation frequency
研究概览
简要总结
The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients
详细描述
Patients are selected according to the eligibility requirements. After being informed about the study and potential risks of neuromodulation, all included patients and next of kin give written informed consent to the study.
At baseline, patients are classified to one of the two predefined subgroups: either medical and behavioral therapy is extended and optimized or neuromodulatory treatment is started with non-invasive sacral nerve stimulation via single current and two external adhesive electrodes. Within 12 weeks, treatment success is evaluated in routine clinical check-ups (week 4/8/12) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 2-17 years
- •informed consent
- •chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling
- •refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training)
- •exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism)
- •in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies
- •in cases of anorectal malformation: post-surgical status
排除标准
- •metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options
- •toxic megacolon or further emergencies, which must be treated surgically
- •fractures or substantial differences in the sacral anatomy
- •inflammatory bowel disorders
- •rectal prolapse
- •neuronal malignancies under medical and radiation therapy
研究组 & 干预措施
Non-invasive Neuromodulation
Application of non-invasive sacral nerve stimulation for 12 weeks, at least 8 hours per day.
Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field with a 15 Hz frequency for a duration of 210µs. Stimulation intensity is individually determined to achieve an effective and comfortable stimulation beyond the pain threshold (adjustable amplitude between 0-10mA).
Medical and behavioral therapy is to be continued as started before intervention.
干预措施: Non-invasive Neuromodulation (Device)
Medical/behavioral Therapy
Patients receive an optimized conventional treatment for 12 weeks, including lifestyle changes, toilet training and weight-adjusted medication. Conventional medical options include oral laxative medication with polyethyleneglycol or rectal medication with saline enemas in possible combination with a stimulant laxative (glycerin or bisacodyl).
干预措施: Medical and Behavioral Therapy (Other)
结局指标
主要结局
Symptoms: Change in defecation frequency
时间窗: Baseline and 12 weeks after start of therapy
Defecation frequency is measured by bowel movements per week.
Symptoms: Change in defecation consistency
时间窗: Baseline and 12 weeks after start of therapy
Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency).
Change in Quality of Life
时间窗: Baseline and 12 weeks after start of therapy
The quality of life is classified via the 'Revised Children's Quality of Life Questionnaire' (KINDLR). It consists of 24 5-point Likert-scale items, covering 6 quality of life dimensions: physical well-being, emotional well-being, self-esteem, family, friends and daily functioning (school or nursery school/kindergarten). Items are partially reverse scored and linearly transformed to a 0 to 100 scale according to the manual. Higher scores indicate a better quality of life.
Symptoms: Change of encopresis/soiling
时间窗: Baseline and 12 weeks after start of therapy
Episodes of encopresis/soiling are evaluated per day.
次要结局
- Symptoms: Change of abdominal pain(Baseline and 12 weeks after start of therapy)
研究者
Dr. med. Sonja Diez
M.D.
Friedrich-Alexander-Universität Erlangen-Nürnberg